Efficacy of melatonin, low-dose quetiapine, or placebo in adolescents with psychiatric disorders and comorbid insomnia: a randomized clinical trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519597-39-00

Enrollment

255

Registered

2025-04-14

Start date

2025-08-18

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F84, F90-F95) and insomnia, Psychiatric disorder (ICD-10 F20-F69

Brief summary

Insomnia severity using the Insomnia Severity Index (ISI)

Detailed description

Clinical global impression (CGI), Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI), Psychosocial functioning using the Personal and Social Performance Scale (PSP), Patient-reported subjective well-being using the WHO-5 well-being index, Rest-sleep-activity cycles and physiological variables

Interventions

DRUGMelatonin Orifarm 3 mg filmdragerade tabletter

DRUGQuetiapin Sandoz 25 mg filmdrasjerte tabletter

DRUGStarch and Lactose containing gelatine capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Insomnia severity using the Insomnia Severity Index (ISI)	—

Secondary

Measure	Time frame
Clinical global impression (CGI), Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI), Psychosocial functioning using the Personal and Social Performance Scale (PSP), Patient-reported subjective well-being using the WHO-5 well-being index, Rest-sleep-activity cycles and physiological variables	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026